MSAT Scientist III, Upstream
Core
Lead technology transfer, process validation, and manufacturing support for upstream cGMP viral vector production to enable gene therapies.
Role type
Senior Manufacturing Sciences Scientist (Upstream)
Builds
Late-stage clinical and commercial gene transfer vector products
Domain
Biopharmaceuticals / Cell and Gene Therapy / Upstream Processing
Required skills
Upstream biopharmaceutical manufacturing, Process development, Technology transfer, GMP compliance, Root cause analysis, CAPA implementation, Process validation, Risk assessment, Data analysis, Equipment qualification
Preferred skills
Adherent mammalian cell culture (HEK), Stirred tank/single-use bioreactors, Cellstacks/Hyperstacks/iCellis, Late-stage commercial scale-up, Cell and gene therapy vector production
Technologies
Stirred Tank Bioreactors, Single-use Bioreactors, Cellstacks, Hyperstacks, iCellis
Responsibilities
Lead technology transfer for upstream cGMP manufacturing; Author PPQ protocols and reports; Monitor and trend process performance; Investigate root causes of major deviations and implement CAPA; Collaborate with cross-functional teams on process definition and facility fit assessments; Support engineering teams on equipment selection and qualification.
Seniority
Senior, hands-on IC